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Arthritis clinical trials

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NCT ID: NCT04580225 Recruiting - Arthritis Clinical Trials

Randomized Comparison of PARtial Wrist Fusion With or Without Triquetral Excision (PARTE)

PARTE
Start date: January 7, 2021
Phase: N/A
Study type: Interventional

This randomized clinical trial (RCT) aims to compare clinical and radiographic outcomes of different partial wrist fusion techniques in participants with post-traumatic wrist arthritis. Participants with stage II or III scapholunate advanced collapse (SLAC) or scaphoid nonunion advanced collapse (SNAC) who meet the eligibility criteria will be randomly assigned to one of two parallel groups: Group A (partial wrist arthrodesis without triquetral excision i.e. four-corner arthrodesis), or Group B (partial wrist arthrodesis with triquetral excision i.e. three-corner or capitolunate arthrodesis with triquetral excision). The results of this study will provide evidence to guide surgeons in determining the ideal wrist fusion technique in the management of patients with post-traumatic wrist arthritis requiring surgery.

NCT ID: NCT04541810 Recruiting - Clinical trials for Rheumatoid Arthritis (RA)

A Study of Oral Upadacitinib (RINVOQ) Tablets to Assess Adverse Events and Change in Disease Symptoms in Korean Participants With Moderate to Severe Active Rheumatoid Arthritis, Atopic Dermatitis, Ankylosing Spondylitis or Psoriatic Arthritis

Start date: January 26, 2021
Phase:
Study type: Observational

Rheumatoid Arthritis (RA) is an inflammatory disease of the joints characterized by the swelling of multiple joints and tenderness caused by progressive inflammatory synovitis, which leads to serious and debilitating diseases. Atopic dermatitis (AD) is a skin condition that may cause a rash and itching due to inflammation of the skin. Ankylosing Spondylitis (AS) is a form of chronic arthritis causing inflammation in the spine. This can cause pain and stiffness in the back. Psoriatic arthritis (PsA) is a type of arthritis (swelling and stiffness in the joints) that is frequently seen in trial participants who also have the skin condition psoriasis. It is caused by the body's immune system mistakenly attacking healthy joint tissue causing inflammation, joint damage, disability, and a reduced life expectancy. This study will assess the adverse events and change in disease symptoms in Korean participants with RA, AD, AS or PsA. Upadacitinib is a drug approved for the treatment of moderately to severely active rheumatoid arthritis, atopic dermatitis, ankylosing spondylitis or psoriatic arthritis. Korean participants who have been prescribed upadacitinib by their physicians will be enrolled. Approximately, 3600 participants will be enrolled this study, in multiple sites within Korea. Participants will receive Upadacitinib as prescribed by the physician and will be followed for approximately 28 weeks. There will be no additional burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic and will be asked to provide additional information by questionnaire at each visit.

NCT ID: NCT04530305 Recruiting - Clinical trials for Rheumatoid Arthritis

Microbiota Analysis to Predict Outcomes of Rheumatoid Arthritis Patients Treated With JAK-inhibitor

MARAJA
Start date: January 7, 2021
Phase:
Study type: Observational

Personalized medicine in which each patient would receive the ideal personalized treatment and regimen, holds great promise to improve patient's care. However, previous studies failed to establish validated predictors of response to disease-modifying anti-rheumatic drugs (DMARDs) in patients with rheumatoid arthritis (RA). JAK inhibitors is a new class of DMARDs with great efficacy that might be even superior to anti-TNF drugs. As there are chemicals, their production cost is much cheaper than biological therapies and they will probably be central in patient's care in the coming years. Three are currently available: upadacitinib (UPA) tofacitinib and baricitinib. Our study will focus on UPA. Clinical outcomes mainly depend on i) factors influencing drug metabolism & concentrations and ii) adequacy between drug target and the inflammation pathways involved in the patient's disease. Humans carry in their gut trillions of germs, which are now known to be key players in health and disease. Those germs possess many enzymes and strongly modulate human enzymes expression. Gut-microbiota can, indeed, directly metabolize oral drugs and control the expression of the cytochrome P450 3A4 (CYP3A4), the main enzyme metabolizing TOFA. We showed, in a preliminary mouse experiment, that modifying gut-microbiota composition changes JAKi effects on signaling pathways. We thus believe that models including gut-microbiota composition together with markers of immune activation will predict clinical outcomes in RA patients treated with UPA. Main and secondary objectives: To build predictive models for clinical outcomes (efficacy and safety) of RA patients treated with UPA based on microbiota analysis and markers f immune activation. Methodolgy: This multicentric longitudinal prospective study will include 60 patients with RA and inadequate response to methotrexate. The clinical outcomes studied will be EULAR non-response at 3 months as defined by the European league against rheumatism EULAR (primary outcome), achievement of low-disease activity at 6 months or incident adverse events (secondary outcomes). Gut microbiota will be assessed at baseline and M3 from thawed fecal samples. DNA will be purified using QIAamp DNA stool mini kit (Qiagen) and qualify using Qubit and TapeStation 4200 (Agilent). Library will be prepared by amplification of V1-V2 and V3-V4 regions from the bacterial 16S rRNA genes and will be qualified by q-PCR and amplicons will be sequenced by MiSeq (Illumina). Initial bioinformatic analysis and taxonomies will be carried out using the QIIME2 software. Immune activation will be assessed through JAK-STAT pathway activation by JAK STAT signaling pathway RT² profiler PCR Array (Qiagen) which profiles expression of 84 genes related to Jak and Stat-mediated signaling. UPA concentrations will be assessed by liquid chromatography-tandem mass spectrometry (LC-MS/MS) at baseline and 3 months. Statistical classifiers (Neural network algorithm, Linear and Quadratic Discriminant Analysis, Support Vector Machine, Random forests, Shrinkage Methods, or Nearest Neighbors) incorporating microbiome, JAK STAT signaling pathway gene expression and clinical data, will be used to determine profiles associated with UPA clinical response and safety. Patients who will prematurely stop UPA (before 3 months) for adverse events or loss of follow-up will be considered as non-responders.

NCT ID: NCT04521998 Recruiting - Clinical trials for Arthritis, Rheumatoid

Comparative Effectiveness Research of Electroacupuncture and TENS in Patients With Rheumatoid Arthritis

Start date: August 4, 2020
Phase: N/A
Study type: Interventional

The aim of this pilot study is to compare the effectiveness of electroacupuncture or transcutaneous electrical nerve stimulation in reducing the tenderness in the patients with rheumatoid arthritis. The study adopted a pragmatic, randomized, patient-centered approach to investigate the effectiveness of clinical symptoms and quality of life.

NCT ID: NCT04517669 Recruiting - Psoriatic Arthritis Clinical Trials

Effectiveness of Treatment With Tofacitinib in Patients With Psoriatic Arthritis in Routine Clinical Practice

Start date: May 17, 2021
Phase:
Study type: Observational [Patient Registry]

This is a Multinational Study of Tofacitinib in Patients Treated for Psoriatic Arthritis in order to evaluate the effectiveness of treatment with tofacitinib on disease activity, remission, and Quality of Life, in a real-world setting over a 12-month observation period

NCT ID: NCT04514614 Recruiting - Arthritis Clinical Trials

Characterizing Rheumatoid Arthritis With 68Ga-FAPI PET/CT

Start date: September 1, 2020
Phase: Early Phase 1
Study type: Interventional

68Ga-FAPI has been developed as a tumor-targeting agent as fibroblast activation protein is overexpressed in cancer-associated fibroblasts and some inflammation, such as IgG4-related disease and inflammatory bowel disease. Some researches identified FAP expression in synovial samples taken from both rheumatoid arthritis and osteoarthritis patients.Thus this prospective study is going to investigate whether 68Ga-FAPI PET/CT may be superior for diagnosis, therapy response assessment and follow-up of arthritis than 18F-FDG PET/CT.

NCT ID: NCT04505982 Recruiting - Clinical trials for Rheumatoid Polyarthritis

Anti IL6R Reduce Complement Serum Level in Rheumatoid Arthritis Patients: Facts and Implications

Start date: July 14, 2020
Phase:
Study type: Observational

Interleukin 6 is identified as a cytokine with pro and anti-inflammatory effects, depending on the context to which it is exposed, exerting a role in the expansion and activation of T lymphocytes, in the survival, expansion and the maturation of B lymphocytes and plasmablasts as well as in the regulation of the acute phase response. The IL-6 receptor complex is a dimer in which each monomer is composed of an 80 kD subunit, IL-6R or CD126, expressed in hepatocytes, leukocytes and in megakaryocytes, which binds IL- 6 and a 130 kD subunit, gp130 or CD130, which is expressed ubiquitously. Its effects are mediated mainly by the way of tyrosine kinases of the Jaks family, and transcription factors of the STATs family. The complement system is made up of a set of plasma proteins, cascading through three activation pathways (classical, alternate and lectin pathway). This system is considered part of innate immunity. It is also part of the acute phase response.The complement has several functions: cell lysis by formation of the membrane attack complex; opsonization and activation of phagocytosis of foreign particles, elimination of circulating immune complexes, and regulation of the adaptive immunity response and inflammation via anaphylatoxins. After reviewing the literature, the link between IL6 and the complement system can be summarized as an induction of factor C3 and factor B, but also probably CD55 (DAF or Decay acceleration factor) and CD59 (MAC-IP or MAC-Inhibitory Protein) by interleukin-6. The effects of IL-6 on the lectin pathway, on the other hand, seem contradictory: inhibition or induction of the synthesis of MASP1 / 3 and 2 depending on the experimental model. It has become common knowledge that anti-IL6 receptor monoclonal antibodies, used in the treatment of patients with rheumatoid arthritis and other inflammatory conditions, reduce the serum levels of acute phase proteins and in particular the levels of CRP. But what about other acute phase proteins and in particular the complement ? A recent study showed that the serum levels of the complement components C3 and C4 were also reduced after the use of tocilizumab and this as early as 4 weeks after the first administration. To the investigator's knowledge, this is the only study reporting a decrease in complement during treatment with anti-IL6R. This study would allow the evaluation of complement parameters in the population of patients under treatment with antiIL6R (tocilizumab or sarilumab) within the CHU Brugmann Hospital in order to - confirm or not this observation - look for a possible secondary clinical consequence - compare this decrease with the activity of the disease in order to see if it could be a marker of effectiveness - put this decrease in parallel with the side effects / tolerance of the treatment in order to see if it could be a marker of toxicity / safety This study will also investigate the subpopulations of B lymphocytes (memory B, transitional B, and plasmablasts) in order to assess whether the evolution of one of these lines would be predictive of a therapeutic response. Secondly, this study would eventually allow - to improve the understanding of the mechanisms of action of the treatment on inflammatory markers by evaluating the activity of the residual complement - to raise the need to find new parameters for monitoring inflammatory activity in these patients, since CRP assays are not very helpful.

NCT ID: NCT04499001 Recruiting - Clinical trials for Arthritis, Rheumatoid

Effect of Pharmaceutical Consultations Just Before Rheumatology Consultations on Improving Knowledge and Skills for Patients With Inflammatory Arthritis With Subcutaneous Biologic DMARDs

Start date: October 1, 2019
Phase:
Study type: Observational

There is a lack of knowledge among patients concerning their treatment with bDMARDs. To increase knowledge and safety skills, patient education is essential. The aim of this study is to assess the impact of a pharmacist's educational interview on on knowledge and safety skills to bDMARDs in patients with inflammatory arthritis.

NCT ID: NCT04497129 Recruiting - Knee Osteoarthritis Clinical Trials

ROMTECH PortableConnect Rehabilitation Device Usage Post Unilateral Total Knee Arthroplasty (TKA)

Start date: August 17, 2020
Phase: N/A
Study type: Interventional

ROMTech is focused on transforming the healthcare market by delivering lower extremity rehabilitation systems that are effective, efficient for patient use, cost-effective, and provide better patient outcomes while simultaneously decreasing rehabilitation and overall recovery times.

NCT ID: NCT04492462 Recruiting - Clinical trials for Total Hip Arthroplasty

The Impact of Two Different Physical Therapy Programs in the Rehabilitation of Patients Undergoing Anterior Approach Hip Replacement Surgery

Start date: October 22, 2019
Phase: N/A
Study type: Interventional

This study will look to determine two different types of physical therapy regimens in patients who undergo anterior total hip replacement. We will compare the results of two groups. The first group, the "Formal Physical Therapy" group, will undergo standard physical therapy following their surgery. They will see a physical therapist in a physical therapy office after their surgery. Here, the therapist will work with the patient to strengthen muscles and improve their walking. The second group, the "Self-directed Physical Therapy" group, will undergo physical therapy in the comfort of their own home using common household items (chairs, steps, etc). These patients will be given a list of exercises and stretches to perform on their own. It is our goal to prove that formal physical therapy is not needed after anterior hip replacements.